Zanaflex
- Product NDC
- 21695-373
- 11-digit product format
- 216950373
- Labeler code
- 21695
- Product ID
- 21695-373_b581d63f-61cb-41b6-a7ca-24bd0b32a8ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tizanidine hydrochloride
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA021447
- Marketing category
- NDA
- Marketing start
- 2002-08-29
- Marketing end
- 0000-00-00
- Substance
- TIZANIDINE HYDROCHLORIDE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a0ff02d8-b711-423c-b7d1-ada00d81c743 | Product name | 1 | 20250805 |
| 9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01 | Product name | 8 | 20250313 |
| b404127e-1c01-47bb-874e-db1e0b6bd9af | Product name | 4 | 20250313 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-373-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4857-48b1-e053-8cdaa90a720a | Zanaflex Capsules ® Zanaflex Tablets ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-373-30 | Zanaflex | 30 in 1 BOTTLE | CAPSULE, GELATIN COATED | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-373-30 | EA - Each | 21695-373 | 91432c8e-8212-4c4a-a019-cf62954750dc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| tizanidine hydrochloride | ACTIVE INGREDIENT | B53E3NMY5C | ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| tizanidine | ACTIVE MOIETY | 6AI06C00GW | ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ZANAFLEX (TIZANIDINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485485 | tiZANidine HCl 4 MG Oral Capsule | PSN | b581d63f-61cb-41b6-a7ca-24bd0b32a8ae | 1 |
| 583211 | Zanaflex 4 MG Oral Capsule | PSN | b581d63f-61cb-41b6-a7ca-24bd0b32a8ae | 1 |
| 583211 | tizanidine 4 MG Oral Capsule [Zanaflex] | SBD | b581d63f-61cb-41b6-a7ca-24bd0b32a8ae | 1 |
| 485485 | tizanidine 4 MG Oral Capsule | SCD | b581d63f-61cb-41b6-a7ca-24bd0b32a8ae | 1 |
| 485485 | tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral Capsule | SY | b581d63f-61cb-41b6-a7ca-24bd0b32a8ae | 1 |
| 583211 | Zanaflex 4 MG (tizanidine hydrochloride 4.58 MG) Oral Capsule | SY | b581d63f-61cb-41b6-a7ca-24bd0b32a8ae | 1 |
| 583211 | Zanaflex 4 MG Oral Capsule | SY | b581d63f-61cb-41b6-a7ca-24bd0b32a8ae | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-373-30 | 21695037330 | 30 in 1 BOTTLE | Historical |